SIST EN ISO 10328:2016
(Main)Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test methods (ISO 10328:2016)
IMPORTANT — This International Standard is suitable for the assessment of the conformity
of lower limb prosthetic devices/structures with the strength requirements specified in 4.4
of ISO 22523:2006 (see NOTE 1). Prosthetic ankle-foot devices and foot units on the market,
which have demonstrated their compliance with the strength requirements specified in 4.4
of ISO 22523:2006 through submission to the relevant tests of ISO 10328:2006, need not be
retested to ISO 22675:2016.
WARNING — This International Standard is not suitable to serve as a guide for the selection of a
specific lower limb prosthetic device/structure in the prescription of an individual lower limb
prosthesis! Any disregard of this warning can result in a safety risk for amputees.
This International Standard specifies procedures for static and cyclic strength tests on lower-limb
prostheses (see NOTE 2) which typically produce compound loadings by the application of a single test
force. The compound loads in the test sample relate to the peak values of the components of loading
which normally occur at different instants during the stance phase of walking.
The tests described in this International Standard comprise
— principal static and cyclic tests for all components;
— a separate static test in torsion for all components;
— separate static and cyclic tests on ankle-foot devices and foot units for all ankle-foot devices as single
components including ankle units or ankle attachments and all foot units as single components;
— a separate static ultimate strength test in maximum knee flexion on knee joints and associated
parts for all knee units or knee-shin-assemblies and adjacent components that normally provide the
flexion stop on a complete prosthesis;
— separate static and cyclic tests on knee locks for all mechanisms which lock the knee joint in the
extended position of the knee unit or knee-shin-assembly.
The tests described in this International Standard apply to specific types of ankle-disarticulation
prostheses (see NOTE 2), to transtibial (below-knee), knee-disarticulation and transfemoral (aboveknee)
prostheses and to the distal (lower) part of hip-disarticulation and hemi-pelvectomy prostheses
(see NOTE 3).
NOTE 1 The tests can be performed on complete structures, on part structures or on individual components.
NOTE 2 The tests only apply to ankle-disarticulation prostheses which include (foot) components of prosthetic
ankle-foot devices taken from the normal production line.
NOTE 3 The distal part comprises the knee unit, the ankle-foot device and all parts between. Tests on hip
units are described in ISO 15032.
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen und Prüfverfahren (ISO 10328:2016)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs - Exigences et méthodes d'essai (ISO 10328:2016)
IMPORTANT ? ISO 10328:2016 permet d'évaluer la conformité des prothèses/structures prothétiques de membre inférieur selon les exigences concernant la résistance spécifiées en 4.4 de l'ISO 22523:2006 (voir la NOTE 1). Les unités de pied et les ensembles cheville-pied prothétiques commercialisés, conformes aux exigences concernant la résistance spécifiées en 4.4 de l'ISO 22523:2006 après soumission aux essais appropriés de l'ISO 10328:2006, sont réputés conformes à l'ISO 22675:2016.
AVERTISSEMENT ? ISO 10328:2016 ne peut pas servir de guide pour choisir une prothèse/structure prothétique lors de la prescription d'une prothèse de membre inférieur ! Ignorer cet avertissement peut entraîner des risques pour la sécurité des personnes amputées.
ISO 10328:2016 spécifie des modes opératoires d'essais de résistance statiques et cycliques des prothèses de membres inférieurs (voir la NOTE 2) qui produisent typiquement des contraintes combinées par l'application d'une force d'essai unique. Les contraintes combinées dans l'échantillon d'essai correspondent aux valeurs maximales des composantes des forces qui interviennent normalement à différents moments au cours de la phase d'appui du cycle de marche.
Protetika - Preskušanje strukture protez spodnjih okončin - Zahteve in preskusne metode (ISO 10328:2016)
POMEMBNO: ta mednarodni standard je primeren za oceno skladnosti protetičnih pripomočkov/struktur za spodnje okončine z zahtevami glede trdnosti, določenimi v točki 4.4 standarda ISO 22523:2006 (glej OPOMBA 1). Protetičnih pripomočkov za gleženj in stopalo ter enot za stopalo, ki so na voljo na tržišču in dokazano izpolnjujejo zahteve, podane v točki 4.4 standarda ISO 22523:2006, na podlagi opravljenih ustreznih preskusov v skladu s standardom ISO 10328:2006, ni treba znova preskusiti v skladu s standardom ISO 22675:2016.
OPOZORILO: ta mednarodni standard ni primeren za uporabo kot vodilo za izbiro določenega protetičnega pripomočka/strukture za spodnje okončine pri predpisovanju posamezne proteze za spodnje okončine. Morebitno neupoštevanje tega opozorila lahko pomeni varnostno tveganje za amputirance. Ta mednarodni standard določa postopke za preskušanje statične in ciklične trdnosti protez za spodnje okončine (glej OPOMBA 2), pri katerih se običajno ustvarijo sestavljene obremenitve na podlagi uporabe enkratne preskusne sile. Sestavljene obremenitve v preskusnem vzorcu se navezujejo na najvišje vrednosti sestavnih delov obremenitve, ki se običajno pojavijo v različnih obdobjih faze drže pri hoji.
Preskusi, opisani v tem mednarodnem standardu:
– glavni statični in ciklični preskus za vse sestavne dele;
– ločen statični preskus pri torziji za vse sestavne dele;
– ločen statični in ciklični preskus za pripomočke za gleženj in stopalo ter enote za stopalo za vse pripomočke za gleženj in stopalo kot samostojne sestavne dele, vključno z enotami za stopalo ali pripomočki za gleženj, ter za vse enote za stopalo kot samostojne sestavne dele;
– ločen statični preskus skrajne trdnosti v največjem upogibu kolena za kolenske sklepe in povezane dele za vse enote za koleno ali sestave za koleno in golen ter soležne sestavne dele, ki običajno zagotavljajo blokado upogiba pri celotni protezi;
– ločen statični in ciklični preskus za kolenske blokade za vse mehanizme, ki blokirajo kolenski spoj v iztegnjenem položaju kolenske enote ali sestava za koleno in golen.
Preskusi, opisani v tem mednarodnem standardu se uporabljajo za posebne vrste protez za disartikulacijo gležnja (glej OPOMBA 2), transtibialne (podkolenske) proteze, proteze za disartikulacijo kolena in transfemoralne (nadkolenske) proteze ter proteze za disartikulacijo distalnega (spodnjega) dela kolka in proteze, ki se uporabljajo po hemipelvektomiji (glej OPOMBA 3).
OPOMBA 1: preskuse je mogoče opraviti za celotne strukture, dele struktur ali posamezne sestavne dele.
OPOMBA 2: preskusi se uporabljajo samo za proteze za disartikulacijo gležnja, ki vključujejo sestavne dele (za stopalo) protetičnih pripomočkov za gleženj in stopalo, vzete iz običajne proizvodne linije.
OPOMBA 3: distalni del zajema enoto za koleno, pripomoček za gleženj in stopalo ter vse vmesne dele. Preskusi za kolčne enote so opisani v standardu ISO 15032.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 10328:2016
01-september-2016
1DGRPHãþD
SIST EN ISO 10328:2006
3URWHWLND3UHVNXãDQMHVWUXNWXUHSURWH]VSRGQMLKRNRQþLQ=DKWHYHLQSUHVNXVQH
PHWRGH ,62
Prosthetics - Structural testing of lower-limb prostheses - Requirements and test
methods (ISO 10328:2016)
Prothetik - Prüfung der Struktur von Prothesen der unteren Gliedmaßen - Anforderungen
und Prüfverfahren (ISO 10328:2016)
Prothèses - Essais portant sur la structure des prothèses de membres inférieurs -
Exigences et méthodes d'essai (ISO 10328:2016)
Ta slovenski standard je istoveten z: EN ISO 10328:2016
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
SIST EN ISO 10328:2016 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 10328:2016
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SIST EN ISO 10328:2016
EN ISO 10328
EUROPEAN STANDARD
NORME EUROPÉENNE
June 2016
EUROPÄISCHE NORM
ICS 11.040.40 Supersedes EN ISO 10328:2006
English Version
Prosthetics - Structural testing of lower-limb prostheses -
Requirements and test methods (ISO 10328:2016)
Prothèses - Essais portant sur la structure des Prothetik - Prüfung der Struktur von Prothesen der
prothèses de membres inférieurs - Exigences et unteren Gliedmaßen - Anforderungen und
méthodes d'essai (ISO 10328:2016) Prüfverfahren (ISO 10328:2016)
This European Standard was approved by CEN on 12 May 2016.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2016 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 10328:2016 E
worldwide for CEN national Members.
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SIST EN ISO 10328:2016
EN ISO 10328:2016 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC . 4
2
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SIST EN ISO 10328:2016
EN ISO 10328:2016 (E)
European foreword
This document (EN ISO 10328:2016) has been prepared by Technical Committee ISO/TC 168 "
Prosthetics and orthoticsa" in collaboration with Technical Committee CEN/TC 293 “Assistive products
for persons with disability” the secretariat of which is held by SIS.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by December 2016, and conflicting national standards
shall be withdrawn at the latest by December 2016.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent
rights.
This document supersedes EN ISO 10328:2006.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria, Croatia,
Cyprus, Czech Republic, Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands,
Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 10328:2016 has been approved by CEN as EN ISO 10328:2016 without any modification.
3
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SIST EN ISO 10328:2016
EN ISO 10328:2016 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC [OJ L 169] aimed to be covered
This European standard has been prepared under a Commission’s standardisation request ‘M/023
concerning the development of European standards related to medical devices’ to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive, and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the
risk management process needs to be in compliance with Directive 93/42/EEC as amended by
2007/47/EC. This means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest
possible level’, ‘minimized’ or ‘removed’, according to the wording of the corresponding essential
requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk has to be in compliance with
Essential Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the
European foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not
addressed by this European Standard.
Table ZA.1 — Correspondence between this European standard and Annex I of Directive
93/42/EEC [OJ L 169]
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
With respect to use in
9.1 5 combination with other devices
or equipment.
With respect to any restrictions
on use which shall be indicated
9.1 20 and 21
on the label or in the instructions
for use.
Only covered for mechanical
12.7.1 5, 7, 8, 9, 10, 15, 16, 17 and 18
strength.
Essential requirement 13.1 is not
fully covered here; only the
13.1 5, 20, and 21.4
aspects
of classification are addressed.
4
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SIST EN ISO 10328:2016
EN ISO 10328:2016 (E)
Essential Requirements Clause(s)/sub-clause(s)
Remarks/Notes
of Directive 93/42/EEC of this EN
Only covered for classification of
13.3 b) 21
the use of the device.
Only covered for limitations due
to body mass limit and specific
13.3 k) 21.2
activities undertaken by the
user.
WARNING 1: Presumption of conformity stays valid only as long as a reference to this European
standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European Union.
WARNING 2: Other Union legislation may be applicable to the product(s) falling within the scope of this
standard.
5
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SIST EN ISO 10328:2016
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SIST EN ISO 10328:2016
INTERNATIONAL ISO
STANDARD 10328
Second edition
2016-06-01
Prosthetics — Structural testing
of lower-limb prostheses —
Requirements and test methods
Prothèses — Essais portant sur la structure des prothèses de membres
inférieurs — Exigences et méthodes d’essai
Reference number
ISO 10328:2016(E)
©
ISO 2016
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SIST EN ISO 10328:2016
ISO 10328:2016(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2016, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
or by any means, electronic or mechanical, including photocopying, or posting on the internet or an intranet, without prior
written permission. Permission can be requested from either ISO at the address below or ISO’s member body in the country of
the requester.
ISO copyright office
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2016 – All rights reserved
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SIST EN ISO 10328:2016
ISO 10328:2016(E)
Contents Page
Foreword .vii
Introduction .viii
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 2
4 Designations and symbols of test forces and moments . 2
5 Strength and related performance requirements and conditions of use .3
6 Coordinate systems and test configurations . 5
6.1 General . 5
6.2 Axes of coordinate systems . 5
6.3 Reference planes . 5
6.3.1 General. 5
6.3.2 Top reference plane, T . 5
6.3.3 Knee reference plane, K . 5
6.3.4 Ankle reference plane, A . 6
6.3.5 Bottom reference plane, B . 6
6.4 Reference points . 7
6.5 Test force . 8
6.6 Load line . 8
6.7 Longitudinal axis of the foot and effective joint centres and centrelines . 8
6.7.1 General. 8
6.7.2 Longitudinal axis of the foot . 8
6.7.3 Effective ankle-joint centre . 8
6.7.4 Effective ankle-joint centreline .10
6.7.5 Effective knee-joint centreline .10
6.7.6 Effective knee-joint centre .11
6.8 Reference distances .11
6.8.1 Offsets .11
6.8.2 Combined offsets .11
6.8.3 Effective lever arms L and L .
A K 11
6.8.4 Distance L .
BT 11
7 Test loading conditions and test loading levels .11
7.1 Test loading conditions .11
7.1.1 General.11
7.1.2 Test loading conditions of principal structural tests .12
7.1.3 Test loading conditions of separate structural tests .12
7.2 Test loading levels .12
8 Values of test loads, dimensions and cycles .13
9 Compliance .20
9.1 General .20
9.2 Selection of tests required to claim compliance with this International Standard .21
9.3 Arrangements for tests on samples of prosthetic structures including ankle-foot
devices or foot units, required to claim compliance with this International Standard .21
9.3.1 General.21
9.3.2 Particular arrangements concerning the ankle-foot device or foot unit .21
9.3.3 Particular arrangements and requirements concerning the part required
to connect the ankle-foot device or foot unit to the remainder of the
prosthetic structure .21
9.4 Number of tests and test samples required to claim compliance with this
International Standard .22
9.5 Multiple use of test samples .22
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SIST EN ISO 10328:2016
ISO 10328:2016(E)
9.5.1 General.22
9.5.2 Restriction .22
9.6 Testing at particular test loading levels not specified in this International Standard .23
10 Test samples .25
10.1 Selection of test samples .25
10.1.1 General.25
10.1.2 Selection of ankle-foot devices and foot units of appropriate size of foot .26
10.2 Types of test samples .27
10.2.1 Complete structure .27
10.2.2 Partial structure .29
10.2.3 Any other structure .29
10.3 Preparation of test samples .29
10.4 Identification of test samples .30
10.5 Alignment of test samples .31
10.5.1 Test samples for principal tests and separate tests on knee locks .31
10.5.2 Test samples for separate tests on ankle-foot devices and foot units .31
10.5.3 Test samples for separate static ultimate strength tests in maximum knee
flexion for knee joints and associated parts .31
10.5.4 Test samples for separate tests on knee locks .32
10.6 Worst-case alignment position of test samples .32
11 Responsibility for test preparation .33
12 Test submission document .34
12.1 General requirements .34
12.2 Information required for test samples .35
12.2.1 All test samples .35
12.2.2 Test samples for tests on ankle-foot devices and foot units .35
12.2.3 Test samples for static ultimate strength tests in maximum knee flexion
for knee joints and associated parts .35
12.3 Information required for tests .35
12.3.1 General.35
12.3.2 For all tests .35
12.3.3 For static tests in torsion and on ankle-foot devices and foot units .36
12.3.4 For static ultimate strength tests .36
12.3.5 For cyclic tests .36
12.3.6 For tests in torsion .36
12.3.7 For tests on ankle-foot devices and foot units .36
13 Equipment .37
13.1 General .37
13.2 Equipment for the principal tests specified in 16.2 and 16.3 .37
13.2.1 End attachments .37
13.2.2 Jig (optional) .39
13.2.3 Test equipment .40
13.3 Equipment for the separate static test in torsion specified in 17.1 .42
13.3.1 Test equipment .42
13.4 Equipment for the separate tests on ankle-foot devices and foot units specified in 17.2 .42
13.4.1 Test equipment .42
13.5 Equipment for the separate static ultimate strength test in maximum knee flexion
for knee joints and associated parts specified in 17.3 .46
13.5.1 Extension pieces .46
13.5.2 Test equipment to perform static compression loading – (Compression
testing machine or other equipment).46
13.6 Equipment for the separate tests on knee locks specified in 17.4 .46
13.6.1 End attachments .46
13.6.2 Jig (optional) .46
13.6.3 Test equipment .46
14 Accuracy .47
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SIST EN ISO 10328:2016
ISO 10328:2016(E)
14.1 General .47
14.2 Accuracy of equipment .47
14.3 Accuracy of procedure .47
15 Test principles .48
15.1 General .48
15.2 Static test procedure .48
15.3 Cyclic test procedure .48
16 Test procedures – Principal structural tests.48
16.1 Test loading requirements .
...
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